CN110337311A - Dose measurement and drug for drug delivery device identify - Google Patents

Abstract

This disclosure relates to the dose measurement system for being used in combination with drug delivery device.In an aspect, system includes module, Module bond to device and including sensor, which can operate to detect the relative angular position for the sensed element for being attached to drug delivery device.System determines the type for the drug for being included by device and/or the type of device based on the Angle Position of the sensed element detected.In another aspect, dose measurement system is used in combination with drug delivery device, which includes the dose during dose delivery relative to actuator rotation.Dose measurement system includes sensor, and can be operated to detect the relative angular position for the sensed element for being attached to during dose delivery dose and the amount of dosage that determination is delivered.Also disclose correlation technique.

Description

Dose measurement and drug for drug delivery device identify

Technical field

This disclosure relates to be used for the electron dose detection system of drug delivery device, and illustratively it is related to electron dose inspection Module is surveyed, is suitable for being removably attached to the proximal part of drug delivery device.Alternatively, dose measurement module can be with medicine Object delivery apparatus is integral.Dose delivery detection system can be operated to detect the agent of the drug delivered by drug delivery device The type of drug included in the amount and/or drug delivery device of amount.

Background technique

The patient for suffering from various diseases often must inject drug to oneself.In order to allow people conveniently and accurately oneself Drug is applied, a variety of devices for being collectively referred to as pen-type injector or injection pen have been developed.In general, these pens are equipped with cylindrantherae, The cylindrantherae includes piston and includes the liquid medicine amount repeatedly according to dosage fed.Drive member can be moved forward to push away in cylindrantherae Into piston, included drug is distributed usually to pass through needle from the outlet of cylindrantherae far-end.In disposable or pre-filled pen, After having utilized drug supply of the pen discharge in cylindrantherae, entire pen is abandoned and begins to use new replacement pen by user.Can In the pen of reuse, after having utilized the drug supply in pen discharge cylindrantherae, pen is dismantled to allow to be replaced with new cylindrantherae The cylindrantherae used up, and then, pen is re-assembled for its subsequent use.

Many pen-type injectors and other drugs delivery apparatus utilize mechanical system, wherein component with the behaviour by device Make and the mode of dose proportional that delivers relative to each other rotationally and/or translationally.Therefore, it is reliable to have been working on offer for this field System, these systems accurately measure the relative movement of the component of drug delivery device to estimate delivered dosage.This The system of sample may include sensor, which is fixed to the first component of drug delivery device and detection is fixed to device Second component sensed component relative movement.

The application of appropriate amount of drug requires by the dosage that drug delivery device is delivered to be accurate.Many pen-type injectors and Other drugs delivery apparatus does not include the function of detecting and record automatically the amount of the drug by device delivering during injection event. In the case where automated system is not present, patient must track amount and the time of per injection manually.Therefore, it is necessary to such Device: it can be operated to detect the dosage delivered during injection event by drug delivery device automatically.Furthermore, it is necessary to this The dose measuring systems of sample are removable, and can be reused together with multiple delivery apparatus.In other embodiments, it needs Want such dose measuring systems and delivery apparatus integral.

It is also critically important to deliver correct drug.Depending on situation, patient may need to select different drug or difference The given drug of form.If what drug to be in drug delivery device aspect error at, will be unable to patient suitably to Dosage is sent, and the record of dosage application will be inaccurate.If using the drug for being included by drug delivery device is automatically confirmed that Type dose measuring systems, then a possibility that this thing happens substantially reduces.

Summary of the invention

This disclosure relates to following drug delivery device, with dose measurement system and associated control system, quilt It is configured to based on the amount for determining the drug delivered from drug delivery device to the sensing of the relative rotation in drug delivery device. Relative rotation can occur between the dose and actuator and/or shell of drug delivery device.Dose delivery detection System includes being attached to the electronic equipment assembly of actuator and being attached to or the sensed component including dose.Electronics Apparatus assembly includes rotation sensor, which can operate together with sensed component to detect during dose delivery Rotation of the dose relative to actuator.Electronic equipment assembly may also include various additional components, such as, one or more A other sensors, memory, processor, controller, battery etc..Dose delivery detection system and appended electronic equipment assembly can It is completely integral with pen.

In another aspect, dose delivery detection system includes the mould that can be removably attached to drug delivery device Block.Among other advantages, it attaches and the operation of dismountable dose delivery detection module is to detect delivered medication amount, Functions or operations without changing the drug delivery device attached by it.In some embodiments, provide redundant sensor with Increase the robustness of dose sensing system.In some embodiments, sensing system records the size of delivered dosage and will believe Breath is passed to external device (ED).It will be appreciated by those of ordinary skill in the art that other advantages.

In in a further aspect, dosage forms detection system is provided, can be operated to detect the class of drug delivery device The type of drug included in type and/or drug delivery device.Dosage forms detection system includes removedly being attached To the module of actuator means.The module includes sensor element, which, which is able to detect, is attached to drug delivery dress The sensed component set.The module is bonded to be attached to drug delivery device in predetermined angle position.Sensor can operate with Sensed Angle Position of the component relative to sensor is detected, with the type for the drug that determination is included by drug delivery device.

In another aspect, which includes both drug delivery system and drug type detection system, to detect The amount of the drug of delivering and both the types of drug for being included by drug delivery device.It further include for determining delivered agent The method of the amount of amount and/or the type for the drug for being included by drug delivery device.

Detailed description of the invention

Consider in conjunction with attached drawing make it is described in detail below when, the feature and advantage of the disclosure will become for this field Technical staff becomes apparent.

Fig. 1 is the perspective view of illustrative drug delivery apparatus, and the dose measurement system of the disclosure can be filled with the drug delivery It sets and operates together.

Fig. 2 is the sectional perspective view of the illustrative drug delivery apparatus of Fig. 1.

Fig. 3 is the perspective view of the portions of proximal of the illustrative drug delivery apparatus of Fig. 1.

Fig. 4 is dose delivery detection system of the portions of proximal together with the disclosure of the illustrative drug delivery apparatus of Fig. 1 Partially exploded perspective view.

Fig. 5 is the side diagrammatic view of the broken section of dose measurement system module according to another exemplary embodiment, should Dose measurement system module is attached to the portions of proximal of drug delivery device.

Fig. 6 is the cross-sectional view of the module of dose delivery detection system accoding to exemplary embodiment, which is attached to medicine The portions of proximal of object delivery apparatus.

Fig. 7 is top diagrammatic view, and it illustrates the detections that is oriented accoding to exemplary embodiment to be attached to dosage and set The magnetism for determining component is sensed the rotation sensor of element.

Fig. 8 be include magnetic sensed element Fig. 7 dose perspective view.

Fig. 9 is the perspective view of the alternate embodiment of magnetic dose delivery detection system.

Figure 10 A to Figure 10 B and Figure 11 A to Figure 11 B is shown using the magnetic dose delivery detection system sensed again Other exemplary embodiments.

Figure 12 A to Figure 12 D and Figure 13 A to Figure 13 G shows the example of the dose measurement system using inductive sensing Property embodiment.

Figure 14 is to Figure 17 shows the exemplary embodiments of the bonding system useful to dosage forms delivery system.

Figure 18 is the cross-sectional view of the module of dose measurement system according to another embodiment, which is illustrated as being attached to medicine The portions of proximal of object delivery apparatus.

Figure 19 is to show determining for sensor and sensed component useful in the exemplary embodiment of dose measurement system The diagrammatic view of position.

Figure 20 is the schematic diagram for showing the dose measurement system of Figure 19.

Figure 21 is the curve graph for showing the output response of dose measurement system of Figure 19.

Figure 22 is the cross-sectional view of dose measurement system according to another embodiment, and wherein sensor and sensed element are collected At into drug delivery device.

Figure 23 A to Figure 23 C shows rotation and/or the position using skirt section relative to sensor element with diagrammatic view The exemplary embodiment of the dose measurement system of optical sensing.

Figure 24 A to Figure 24 B with diagrammatic view show using flange (flange) relative to sensor element rotation and/ Or the another exemplary embodiment of the dose measurement system of the optical sensing of position.

Figure 25 A to Figure 25 C shows the exemplary embodiment of the dose measurement system using capacitance type sensing.

Figure 26 is the cross-sectional view of the other illustrative drug delivery apparatus of the disclosure.

Specific embodiment

For the purpose for promoting the understanding to the principle of the disclosure, with reference to the drawings in shown embodiment, and And these embodiments will be described using language-specific.However, it will be understood that not thus being intended to limit the scope of the invention.

This disclosure relates to be used for the sensing system of drug delivery device.In an aspect, sensing system be used for based on pair The sensing of relative rotation movement between the dose and actuator of drug delivery device passes through drug delivery to determine The amount for the dosage that device is delivered.The relative angular position or movement sensed is associated with the amount of the dosage delivered.Second In aspect, sensing system is used for the type for the drug for being included by determining drug delivery device.Pass through explanation, drug delivery device It is described as in the form of pen-type injector.However, drug delivery device can be for setting and delivering dose drug Any device, such as infusion pump, bolus injection device or automatic injector assembly.Drug, which can be, to be filled by such drug delivery Set any drug of the type of delivering.

Device (such as, device 10) described herein may also include drug, such as, in storage or cylindrantherae 20 It is interior.In another embodiment, system may include one or more devices, and described device includes device 10 and drug.Term " medicine Object " refers to one or more therapeutic agents, including but not limited to insulin, insulin analog (such as, insulin lispro or sweet essence Insulin), insulin derivates, GLP-1 receptor stimulating agent (such as, Du Lalu peptide or Liraglutide), glucagon, pancreas it is high Blood glucose element analog, glucagon derivative, gastrointestinal inhibitory peptide (GIP), GIP analog, GIP derivative, oxyntomodulin Analog, oxyntomodulin derivative, therapeutic antibodies and any therapeutic agent that can be delivered by apparatus above.Such as device Used in drug can be prepared together with one or more excipient.Device is by patient, nursing staff or health care profession Personnel by usually as described above in a manner of operate with by drug delivery to people.

Illustrative drug delivery apparatus 10 is illustrated as pen-type injector in Fig. 1 to Fig. 4, which is constructed At by needle by drug injection to patient's body.Pen-type injector 10 includes main body 11, which includes elongated pen shape shell 12, which includes distal part 14 and portions of proximal 16.Distal part 14 is received in pen cap 18.With reference to Fig. 2, distal portion Dividing 14 includes storage or cylindrantherae 20, and the storage or cylindrantherae are configured to accommodate during staying in batch operation through distal part 14 The drug fluid of distal outlet end distribution.The outlet end of distal part 14 includes equipped with removable needle assemblies 22, the needle assemblies By the closed injection needle 24 of removable cap 25.Piston 26 is positioned in storage 20.The injection being positioned in portions of proximal 16 Mechanism operation with during dosage batch operation towards the outlet propelling piston 26 of storage 20, to force included drug to pass through End with a needle.Injection mechanism includes drive member 28(illustratively in the form of screw), which can be relative to shell 12 axial movements pass through storage 20 with propelling piston 26.

Dose 30 is connected to shell 12, with the amount for setting the dosage to be distributed by device 10.Schemed In the embodiment shown, dose 30 is in the form of screw elements, and operation is during dosage setting and dosage distribute It is (that is, axially and rotationally moving simultaneously) for the helical movement relative to shell 12.Fig. 1 and Fig. 2 illustrate dose 30, which is fully screwed in shell 12 and is in its original position or zero dose position.Dose 30 operations correspond to and can be passed in single injection by device 10 until it is reached to screw outward from shell 12 in a proximal direction Until the fully extended position of the maximum dose sent.

Referring to figs. 2 to Fig. 4, dose 30 includes the tubular dose dial with the outer surface with helical thread Component 32, the corresponding threaded inner surface of the appearance face bonding shell 12 is with acceptable dose setting element 30 relative to shell 12 It is for the helical movement.Dose dial component 32 further includes the inner surface with helical thread, the sleeve of the inner surface engagement device 10 34(Fig. 2) threaded exterior surface.The outer surface of dial member 32 includes dosage indicator mark, such as passes through dosage window 36 It can be seen that the number of the amount of the dosage to indicate to the user that setting.Dose 30 further includes tubular flange 38, and the tubulose is convex Edge is connected in the open proximal end of dial member 32 and is axially and rotationally locked to dial member 32 by pawl 40, described Pawl is received in the opening 41 in dial member 32.Dose 30 further includes lantern ring or skirt section 42, the lantern ring or Skirt section is located in its proximal end around the outer periphery of dial member 32.Skirt section 42 is axial by the lug 44 being received in slot 46 Ground and it is rotationally locked to dial member 32.

Therefore, dose 30 can be believed to comprise any in dose dial component 32, flange 38 and skirt section 42 Person or whole, because all of which is all rotationally and axially fixed together.Dose dial component 32 directly participates in setting agent The delivering of amount and driving drug.Flange 38 is attached to dose dial component 32, and as described later, with clutch engagement Selectively dial member 32 to be coupled with dose button 56.Skirt section 42 provides the surface outside main body 11, so that handy Family can revolving dial component 32 with setting dosage.

Skirt section 42 illustratively includes cyclic annular spine 49 and multiple surface characteristics 48 on the outer surface for being formed in skirt section 42. Surface characteristics 48 is illustratively that the flank and groove longitudinally extended, these flanks and groove are circumferential around the outer surface in skirt section 42 Ground is spaced apart and catches and rotating skirt convenient for user.In an alternative embodiment, skirt section 42 be removed or with driver plate structure Part 32 is integral, and user can catch and dose button 56 and/or dose dial component 32 are to carry out dosage setting.? In the embodiment of Fig. 4, user can catch and rotate the radially-outer surface of single type dose button 56 to carry out dosage setting, this one Part formula dose button also includes multiple surface characteristics.

Delivery apparatus 10 includes the actuator 50 with clutch 52, which is received in dial member 32.From Clutch 52 is located to include axially extending bar (stem) 54 at its proximal end.Actuator 50 further includes being positioned in dose 30 Skirt section 42 nearside dose button 56.In an alternative embodiment, dose 30 includes one shown in Figure 26 Part formula dose button 56.Dose button 56 includes the mounting collar 58(figure being centrally located in the distal surface of dose button 56 2).Lantern ring 58 is attached to the bar 54 of clutch 52, such as using interference fit or ultrasonic welding, so as to axially and rotatably Dose button 56 and clutch 52 are fixed together.

Dose button 56 includes that disk shaped proximal face or face 60 and annular wall part 62, the annular wall part are distally extending And it radially inwardly is spaced apart to form annular lip 64 with the outer peripheral edge in face 60.The nearside of dose button 56 Face 60, which is used as, pushes surface, can be manually (that is, directly by user) against the promotion surface applied force in a distal direction Push actuator 50.Dose button 56 illustratively includes the depressed section 66 being centrally located in proximal side 60, but nearside Face 60 alternatively can be flat surfaces.Similarly, single type dose button 56 shown in Figure 26 may include status placed in the middle In the depressed section 66 in proximal side 60, or it alternatively can be flat surfaces.Biasing member 68(is illustratively bullet Spring) it is placed between the distal surface 70 of button 56 and the proximal face 72 of tubular flange 38, to push actuator 50 and agent Measure setting element 30 axially away from each other.Dose button 56 can be pressed by user to start dosage batch operation.

Delivery apparatus 10 can be operated with both dosage setting mode and dosage allocation model.In dose setting operation mode In, dose 30 is stirred (rotation) relative to shell 12, to set the desired amount to be delivered by device 10.Close The dosage stirred for increasing setting in side direction, and the dosage stirred for reducing setting in a distal direction.Dosage Setting element 30 can be during dose setting operation to correspond to the rotation that the smallest incremental formula of the dosage of setting increaseds or decreases Increment (for example, click sound) is adjusted.For example, an increment or " click sound " can be equal to the drug of half or one unit.Through By by the dial indicator mark shown in dosage window 36, the amount of the dosage of setting is visible to user.In dosage setting mode In stir during, actuator 50 including dose button 56 and clutch 52 and dose 30 are together axially and rotation It is mobile to turn ground.

Due to the threaded connection of dose dial component 32 and shell 12, dose dial component 32, flange 38 and skirt section 42 are complete Portion is all mutually rotatingly fixed, and rotates and extend to the nearside of drug delivery device 10 during dosage setting.In the agent Amount setting movement during, dose button 56 passes through flange 38 and clutch 52(Fig. 2) complementary splines 74 relative to skirt section 42 It rotatably fixes, is pushed together by biasing member 68.During dosage setting, skirt section 42 and dose button 56 In a spiral manner relative to shell 12 since " " position is moved to " end " position.This rotation relative to shell with pass through The amount of dosage set by the operation of drug delivery device 10 is proportional.

Once set at desired amount, with regard to manipulation device 10, therefore injection needle 24 suitably pierces through the skin of such as user. In response to being applied to the axial distal force of the proximal side 60 of dose button 56, start dosage batch operation mode.Axial force by User is applied directly to dose button 56.This causes actuator 50 to move axially in a distal direction relative to shell 12.

The axially displaced motion compresses biasing member 68 of actuator 50, and reduce or close at dose button 56 and tubulose Gap between flange 38.The axially opposite movement separates the complementary splines 74 on clutch 52 and flange 38, and thus Make actuator 50(for example, dose button 56) be detached from and from being rotationally fixed to dose 30.Particularly, dosage is set Determine component 30 and rotatably release with actuator 50 to couple, it is anti-relative to actuator 50 and shell 12 with acceptable dose setting element 30 It is rotated to driving.Dosage batch operation mode can also be started by activating individually switch or trigger mechanism.

As the continuation of actuator 50 is axially injected without rotating relative to shell 12, dial member 32 is at it relative to agent Amount button 56 is reversely screwed in shell 12 when spinning.Indicate that the dosage mark of still remaining amount to be injected passes through window 36 It can be seen that.As dose 30 distad screws downwards, drive member 28 is distally advanced, to push piston 26 to pass through storage Device 20 simultaneously passes through needle 24(Fig. 2) discharge medicine.

During dosage batch operation, it is screwed to back from the amount of the drug of drug delivery device discharge and in dial member 32 Dose 30 is proportional relative to the amount of the moving in rotation of actuator 50 when into shell 12.When in dial member 32 Screw thread arrived sleeve 34(Fig. 2) correspondence externally threaded distal end when, injection is completed.Then, device 10 is arranged to place again In ready state or zero dose position as shown in Figures 2 and 3.

During dose delivery, the beginning and end Angle Position of dose dial component 32 and the flange therefore rotatably fixed 38 and skirt section 42 relative to the beginning and end Angle Position of dose button 56 provide Angle Position it is " absolute " variation.It determines opposite Whether rotation is determining in a number of ways more than 360 °.By example, by the increasing for being additionally contemplates that dose 30 Amount formula is mobile, it may be determined that total rotation, the increment type movement can be measured in a manner of any number kind by sensing system.

In entitled " Medication Dispensing Apparatus with Triple Screw Threads In United States Patent (USP) 7,291,132 of for Mechanical Advantage ", the design of exemplary delivery device 10 can be found With the further details of operation, the complete disclosure of the patent accordingly by being incorporated herein by reference in.Delivery apparatus it is another Example is can be in entitled " Automatic Injection Device With Delay Mechanism Including No. 8,734,394 automatic injections found of United States Patent (USP) of Dual Functioning Biasing member biasing member " Device device, during which is hereby incorporated by reference in its entirety accordingly by reference, wherein utilizing one or more described herein Various sensing systems modify such device, with determined based on the sensing to the relative rotation in drug delivery device from The amount of the drug of drug delivery device delivering.

Dose measurement system uses the sensing part and sensed component for being attached to the component of drug delivery device.Term " attachment " covers any mode that the position of component is fixed to another component or the component fixed to drug delivery device, so that They can be operated as described in this article.For example, sensing part can be attached to drug delivery device in the following manner Component: be positioned directly on the component, be received in the component, integrally or being otherwise connected to the component The component.Connection may include the connection for example formed in the following manner: frictional engagement, spline, be clasped or press-in cooperation, Sound wave welding or adhesive.

Term " directly attachment " is used to describe two of them component or component and component is physically fixed together and does not have There is the attachment of the intermediate member other than attachment component.Attachment component may include its of fastener, adapter or fastening system He is such as located in the compressible membrane between two components in order to attachment in part." directly attachment " is different from its middle part Part/component passes through the coupled connection of one or more intermediate function components, and (such as, dial member 32 passes through clutch in Fig. 2 Device 52 is connected to the mode of dose button 56).

Term " fixation " is used to indicate that indicated movement can to occur or can not occur.For example, if requiring two A component moving in rotation together, then first component and second component " rotatably fixing ".In an aspect, component can be in function It is upper and it is non-structural on relative to another component " fixation ".For example, can make component be pressed against another component make two components it Between frictional engagement they are rotationally fixed together, and two components can not be consolidated in the case where no pressing first component It is scheduled on together.

Envisioned herein various sensing systems.In general, sensing system includes sensing part and sensed portion Part.Term " sensing part " refers to any part for being able to detect the relative position of sensed component.Sensing part includes sensing Element or " sensor " are together with the associated electric component for operating sensing element." sensed component " is such any Component, that is, for it, sensing part is able to detect position and/or movement of the sensed component relative to sensing part.For Dose delivery detection system is sensed component and rotates relative to sensing part, which is able to detect sensed component Angle Position and/or moving in rotation.For dosage forms detection system, sensing part detects the relative angular position of sensed component. Sensing part may include one or more sensing elements, and sensed component may include one or more sensed elements.It passes Sensor system is able to detect (one or more) and is sensed the position of component or movement and provides representative (one or more) and felt Survey (one or more) position of component or the output that (one or more) is mobile.

Sensing system usually detects the characteristic of sensed parameter, which is being felt with the sensed element of one or more The position surveyed in region relatively changes.Sensed element is prolonged in a manner of directly or indirectly influencing the characteristic of sensed parameter It reaches in sensed region or otherwise influences to be sensed region.The relative position of sensor and sensed element influences quilt The characteristic of sensor parameter, so that the controller of sensing system be allowed to determine the different location for being sensed element.

Suitable sensing system may include the combination of active parts and passive component.In sensing part as active parts In the case where operation, it is not necessary to connect two components and other systems element (such as, power supply or controller).

It may be incorporated into any one of a variety of detection technologies, by the detection technology, be able to detect the opposite of two components Position.Such technology may include for example based on tactile, optics, inductance or the technology of electric measurement.

Such technology may include with the measurement of field (such as, magnetic field) associated sensed parameter.In one form, When magnetic part is mobile relative to magnetic sensor, the variation in the sensed magnetic field of magnetic sensor sensing.In another implementation In example, when object be positioned in magnetic field and/or it is mobile pass through magnetic field when, sensing system can sense magnetic field characteristic and/or Variation.Change by sensed element in the position in sensed region it is relevant in a manner of change the spy of sensed parameter Property.In such embodiments, sensed parameter can be capacitor, conductance, resistance, impedance, voltage, inductance etc..For example, magnetic resistance Type sensor detects the distortion in applied magnetic field, which leads to the characteristic variations of the resistance of the element of sensor.As another One example, hall effect sensor detect the voltage change caused by the distortion by the magnetic field applied.

In an aspect, the relative position of the sensed element of sensor system senses or movement and therefore drug delivery dress The relative position for the associated component set or movement.Sensing system generates (one or more) position for representing sensed component Or the output of amount of movement.For example, sensing system can be operated to generate output, can be determined by the output in dosage The rotation of dose during delivering.Controller is operably connected to each sensor to receive output.A side In face, the amount for the dosage that the operation that controller is configured to be determined according to output through drug delivery device is delivered.

The relative rotation that dose delivery detection system is related to detecting between two components is mobile.Degree of rotation with delivered Dosage measurer have known relation in the case where, sensing system operated with detect since dosage injection to dosage infuse Penetrate the angle amount of movement of end.For example, typical relationship is 18 ° of angular displacement phase of dose for pen-type injector When in a dosage unit, but other angular dependences are also suitable.Sensing system can be operated to determine in the dose delivery phase Between dose total angular displacement.Therefore, if angular displacement is 90 °, 5 dosage units have been delivered.

A kind of method for detecting angular displacement is to count when injecting and carrying out to the increment of the amount of dosage.For example, The repeat pattern of sensed element can be used in sensing system, so that repetition is the instruction of scheduled angle number of rotation every time.Have Sharp ground, can such establishment model so that repeating to correspond to the minimum of the dosage using drug delivery device setting every time Increment.

Alternative method is to detect starting position and stop position and the dosage that will be delivered of the component relatively moved Amount be determined as the difference between these positions.In the method, the complete rotation of sensor system senses dose Number can be a part of the determination.Various methods for this completely in the ordinary skill of this field, and It may include carrying out " counting " to incremental number to estimate the number of complete rotation.

Sensing system component can permanently or removably be attached to drug delivery device.In an illustrative embodiment, At least some of dose measurement system unit is provided in the form of the module for being removably attached to drug delivery device.This Have the advantages that so that these sensor elements can be in more than one pen-type injector use.

In some embodiments, sensing part is mounted to actuator, and sensed component is attached to dosage setting structure Part.Sensed component may also include dose or its any part.Sensing system detects quilt during dose delivery The relative rotation of the relative rotation of sensing part and therefore dose is delivered from its determination by drug delivery device Dosage amount.In an illustrative embodiment, rotation sensor is attached and is rotationally fixed to actuator.Actuator is passed in dosage It is not rotated relative to the main body of drug delivery device during sending.In this embodiment, component is sensed to be attached and rotatably consolidate Surely dose is arrived, which rotates during dose delivery relative to actuator and apparatus main body.Felt Surveying component may also include dose or its any part.In an illustrative embodiment, rotation sensor is not attached directly To the dose relatively rotated during dose delivery.

With reference to Fig. 5, dose delivery detection system 80 is shown in diagrammatic form comprising (such as, with drug delivery device Device 10) in conjunction with and useful module 82.82 carry sensors system (generally being shown with 84) of module, the sensing system packet Include rotation sensor 86 and other associated components (such as, processor, memory, battery etc.).Module 82 is provided as Individual component can be removably attached to actuator.

Dose measurement module 82 includes being attached to the main body 88 of dose button 56.Main body 88 illustratively includes cylindrical sidewall 90 and roof 92, the roof is across on side wall 90 and sealing side wall 90.By example, in Fig. 5, upper side wall 90 is illustrated ground It is shown as that there is the lug 94 to extend internally, module 82 is attached to dose button 56 by the lug.Dose measurement module 82 can be replaced Property generation ground via any suitable fastener means (such as, be clasped or press-in cooperation, hickey etc.) be attached to dosage by Button 56, condition are: in an aspect, module 82 can be removed from the first drug delivery device, and be attached to the second drug thereafter Delivery apparatus.Attachment can be at any position in dose button 56, and condition is: dose button 56 can be relative to dosage Setting element 30 axially moves any aequum, as discussed in this article.

During dose delivery, dose 30 is rotated freely relative to dose button 56 and module 82.Illustrating In property embodiment, module 82 is rotatably fixed with dose button 56, and is not rotated during dose delivery.This can in structure It provides in the following manner: such as using the lug of Fig. 5 94, or it is mutual in module bodies 88 and dose button 56 by making Spline or other surfaces the feature engagement when module 82 is moved axially relative to dose button 56 faced.In another embodiment In, module is distad pressed and provides enough frictional engagements between module 82 and dose button 56, so as to functionally Module 82 and dose button 56 is caused to may remain rotationally fixed together during dose delivery.

Roof 92 is spaced apart with the face 60 of dose button 56, and thus provides chamber 96, in rotation sensor and other component Some or all may be housed in the chamber.Chamber 96 can open at bottom, or can be closed (such as, by bottom wall 98). Bottom wall 98 can be positioned to directly bear against on the face 60 of dose button 56.Alternatively, bottom wall 98(if there is Words) it can be spaced apart with dose button 56, and other contacts between module 82 and dose button 56 can be used, so that being applied Axial force to module 82 is passed to dose button 56.In another embodiment, module 82 can be rotationally fixed to Figure 26 Shown in single type dose button 56.

In an alternative embodiment, module 82 is instead attached to dose 30 during dosage setting.For example, Side wall 90 may include the lower wall portion 100 with inward projection 102, and the inward projection is in the position below spine 49 It is engaged with skirt section 42.In the method, lug 94 can be cancelled, and module 82 effectively engages the proximal side 60 of dose button 56 With the distal side of cyclic annular spine 49.In the configuration, lower wall portion 100 can be equipped with surface characteristics, these surface characteristics and skirt The surface characteristics in portion 42 is engaged rotatably to fix module 82 and skirt section 42.Shell is applied to during dosage setting as a result, The rotary force of body 82 is coupled due to lower wall portion 100 and skirt section 42 and is passed to skirt section 42.

Module 82 is rotatably detached from from skirt section 42, to carry out dose delivery.Lower wall portion 100 couples quilt with skirt section 42 It is configured to the disconnection when module 82 is distad moved axially relative to skirt section 42, thus allows the phase during dose delivery of skirt section 42 Module 82 is rotated.

In a similar way, module 82 can couple during dosage setting with both dose button 56 and skirt section 42.This tool There is the advantages of providing additional contact surface during module rotation in dosage setting.Then, it is discharged before dosage injection Module 82 arrives the connection in skirt section 42, such as, by moving axially module 82 relative to skirt section 42, by This acceptable dose setting element 30 rotates during dose delivery relative to module 82.

In certain embodiments, rotation sensor 86 is connected to side wall 90, for detecting sensed component.Lower wall portion 100 are also used to reduce when dose 30 hand of user when rotating during dose delivery relative to module 82 and shell 12 A possibility that applying resistance to it unintentionally.Further, since dose button 56 is rotationally fixed to agent during dosage setting Setting element 30 is measured, therefore side wall 90(includes lower wall portion 100) single continuous surface is provided, the surface is during dosage setting It can be easy to be caught and manipulated by user.

When starting injection process by pressing down on dose measurement module 82, dose button 56 and dose 30 It is rotationally fixed together.Module 82 and the therefore movement of 56 short distance of dose button (for example, less than 2 mm) release rotation Switching is closed, and dose 30 is rotated as dosage is delivered relative to module 82.Either by using thumb pad Or other trigger mechanisms, dose measurement system is all to have moved enough distances in dose button 56 to be detached from dose button 56 It is activated before with the spin locking of dose 30.

Illustratively, dose delivery detection system includes being suitable for the operation of sensing system as described in this article Electronic equipment assembly.Controller is operably connected to sensing system and is exported with receiving from one or more rotation sensors. Controller may include the conventional component being for example comprised in the chamber 96 limited by module bodies 88, such as processor, power supply, Memory, microcontroller etc..Alternatively, at least some components can be provided separately, such as, by means of computer, smart phone Or other devices.Then, device is provided operationally to connect peripheral control unit component with sensing system in reasonable time It connects, such as, passes through wired or wireless connection.

Example electronic device component 120 includes the flexible printed circuit board (FPCB) with multiple electronic components.Electronics Apparatus assembly includes sensing system, which includes one or more rotation sensors 86, the rotation sensor It is operatively communicated with processor for receiving the signal for representing the relative rotation sensed from sensor.Electronic equipment assembly It further include micro controller unit (MCU), which includes at least one processing core and internal storage.System includes that battery (is said It is bright property button cell) for powering to component.MCU includes control logic, and control logic operation is to execute herein Described operation passes through drug delivery including the rotation based on the dose detected relative to actuator to detect The dosage that device 10 is delivered.In one embodiment, detected rotation is the dosage in skirt section 42 and pen-type injector Between button 56.

MCU operation is stored in local storage (for example, on internal flash memory or plate with the dosage that will test EEPROM in).MCU is also operated through Bluetooth Low Energy (BLE) or other suitable short distances or long-distance radio communication The signal for representing the dosage detected is wirelessly transmitted to remote electronic device (such as, the intelligent hand of user of pairing by agreement Machine) and/or from the remote electronic device of the pairing receive the signal.Illustratively, BLE control logic and MCU are integrated in together On one circuit.

Many in sensing electronic equipment is accommodated in chamber 96.However, rotation sensor can be positioned in various positions In, to sense the relative movement of sensed component.For example, rotation sensor can be located at chamber 96 in, be located at main body 88 in but The outside of chamber 96 or in the other positions of main body (such as, on lower wall portion 100).Only requirement is that rotation passes The moving in rotation of sensed component is effectively detected in sensor during being positioned at dose delivery.In some embodiments, it rotates Sensor and device 10 are integral.

The sensed element of one or more is attached to dose 30.In an aspect, it is direct to be sensed element It is attached to the skirt section 42 of dose.Alternatively, sensed element could attach to any one in dose set-ting member Person or more persons, these dose set-ting members include dial member, flange and/or skirt section.Only requirement is that (one or more) It is sensed during the relative rotation that sensed element carries out during being positioned in dose delivery is mobile by rotation sensor.At other In embodiment, sensed component includes dose 30 or its any part.

Fig. 6 provides the other illustrative embodiments of dose delivery detection system 80 into Figure 13.These embodiments with Slightly graphic mode is shown, because providing common details about Fig. 1 to Fig. 5.In general, each embodiment packet The like for including dose measurement module 82, including the main body 88 with tubular upper wall 90 and roof 92.Each embodiment is also wrapped Lower wall 100 is included, but will be appreciated that, the variation (including lower wall 100 is not present) of these components is within the scope of this disclosure.With The shared other parts of relatively early description herein include the electronic equipment assembly being accommodated in the chamber 96 of module bodies 88 120, dose button 56, dose 32 and device housing 12.In addition, in each example, dose measurement module 82 It is shown as with being illustrated being attached to the annular sidewall 62 of dose button 56, but alternative form and the position of attachment can be used.For example, In some embodiments, dose measurement module 82 could attach to dose button 56 and be releasably attached to skirt section 42.Moreover, Dose measurement module 82 could attach to single type dose button 56 as shown in Figure 26.

Each example also illustrates the use of certain types of sensing system.However, in some embodiments, dosage inspection Examining system includes multiple sensing systems using identical or different detection technology.This breaks down in one of sensing system In the case of provide redundancy.It, which is also provided, is appropriately performed using the second sensing system regularly to verify the first sensing system Ability.

In certain embodiments, as shown in Figure 6, be attached to the roof 92 of module 82 is thumb pad 110.Thumb pad 110 It is connected to roof 92, which is then attached to upper side wall 90.Thumb pad 110 include spine 114, the spine extend radially inwardly and It is received in the circumferential grooves 116 of wall components 92.Groove 116 allows the light axial between thumb pad 110 and wall components 92 to move It is dynamic.Spring (not shown) usually pushes up thumb pad 110 far from wall components 92.Thumb pad 110 can be rotationally fixed to wall portion Part 92.When starting injection process, thumb pad 110 can be used for triggering institute towards the axial movement of module bodies 88 in a distal direction The event of selection.One purposes of thumb pad 110 may is that when starting dosage injection, in initial press thumb pad 110 and its phase When moving axially for module bodies 88, drug delivery device electronic equipment is had activated.For example, the initial axial movement can be used for " wake-up " device, and especially component associated with dose measurement system.In one example, module 82 include for The display of user's instruction information.Such display can be integrated with thumb pad 110.MCU includes display drive software module and control Logic processed is operated to receive and handle the data sensed and show information on the display, and such as, dosage is set The time that dosage, injection state, injection completion, date and/or time or next time fixed, distributed inject.

Be not present thumb pad in the case where, can in a manner of various other activation system electronic equipment.For example, can directly examine Initial axial movement of the module 82 when dose delivery starts is surveyed, such as, passes through closure contact or the physical engagement of switch.Also Know based on various other movements and activate drug delivery device, for example, remove pen cap, using accelerometer detection pen it is mobile or Setting dosage.In many methods, the activator amount detection systems before dose delivery starts.

With reference to Fig. 6 to Fig. 8, dose measurement module 82 is operated using Magnetic sensing system 84.Two magnetic sensors 130 are positioned in lower wall portion 100(illustratively, the inner surface of lower wall portion 100) on and the skirt with dose 30 Portion 42 is opposite.For all embodiments, (one or more) rotation sensor and (one or more) sensed member can be changed The number and location of part.For example, the embodiment of Fig. 6 to Fig. 8 alternatively includes between surrounding skirt section 42 homogeneously or heterogeneously Any number of magnetic sensor 130 separated.Sensed component 132(Fig. 7 and Fig. 8) it include being fixed to skirt section 42(explanation Property, on the inside in skirt section 42) magnetic strap 134.In an illustrative embodiment, band includes 5 pairs of North-south magnetic portions Part, such as 136 and 138, therefore each magnetic part extends up to 36 °.Magnetic sensor 130 with 18 ° of positioned at intervals (Fig. 7), And the digit position and the therefore digit position in skirt section 42 of magnetic strap 132 are read in a manner of 2 Gray codes.For example, when passing When sensor detects a N-S magnetism to passing through, detect that skirt section 42 has rotated 36 °, this, which corresponds to, adds (or subtracting) such as 2 The dosage of a unit.

Other magnetic modes can also be used, different numbers or position including magnetic element.In addition, in alternate embodiment In, sensed component 133 is attached to the flange 38 of dose 30 or is integral with, as shown in Figure 9.

As described earlier, sensing system 84 is configured to detect sensed element relative to magnetic sensor 130 Rotation amount.The amount of the rotation amount and the dosage delivered by device is directly associated.By detecting the skirt section during dose delivery 42 movement determines relative rotation, for example, the difference between the starting position and stop position that pass through identification skirt section 42, or " counting " is carried out by the mobile number of the increment type to the skirt section 42 during drug delivery.

With reference to figures 10 to Figure 11, exemplary magnetic sensor system 150 is shown comprising the ring as sensed element Shape, ring bipolar magnet 152, the magnet have the arctic 154 and the South Pole 156.Magnet 152 is attached to flange 38, and therefore in agent It is rotated together with flange during amount delivering.Magnet 152 is alternatively attached to dose dial 32 or revolves with dose Turn other fixed components of ground.

Sensing system 150 further includes sensor 158, the sensor electricity which includes and be accommodated in module 82 One or more sensing elements 160 that sub- equipment (not shown) is operatively connected.The sensing element 160 of sensor 158 is being schemed It is illustrated as being attached to printed circuit board 162 in 11A, which is then attached to module 82, which rotatably fixes To dose button 56.Therefore, magnet 152 rotates during dose delivery relative to sensing element 160.Sensing element 160 can be grasped Make to detect the relative angular position of magnet 152.Biosensor systems 150 are operated as a result, with detect flange 38 relative to Total rotation of dose button 56 and the therefore rotation during dose delivery relative to shell 12.

In one embodiment, biosensor systems 150 include radiuses are waited in module 82 (equi-radially) Four sensing elements 160 at interval.The alternative number and location of sensing element can be used.For example, another shown in Figure 11 B In one embodiment, single sense element 160 is used.In addition, the sensing element 160 in Figure 11 B is illustrated as in module 82 between two parties, Other positions but can also be used.In the aforementioned embodiment, sensing element 160 is illustrated as being attached in module 82.Alternatively, Sensing element 160 could attach to any part of such component: the component is rotationally fixed to dose button 56, so that should Component does not rotate during dose delivery relative to shell 12.

For purposes of illustration, magnet 152 is illustrated as being attached to the individual ring bipolar magnet of flange 38.However, also structure Expect alternative configuration and the position of magnet 152.For example, magnet may include multiple poles, and such as, alternate north and south poles.? In one embodiment, magnet includes multiple extremely right, number of the number equal to the discrete dose setting position of flange 38. Magnet 152 may also include multiple individual magnet structures.In addition, magnet assembly could attach to during dose delivery by rotatably Any part of component fixed to flange 38, such as, skirt section 42 or dose dial component 32.

Alternatively, sensing system is illustrated as inductance type transducer system 170 into Figure 13 in Figure 12.Sensor system System 170 is using the sensed element 171 of the metal tape 172 including being attached to skirt section 42 as sensed element.Sensing system 170 further include sensor 174, which includes one or more sensing elements 176, along radiuses such as the peripheries in skirt section 42 Four stand-alone antennas 178 that ground is spaced apart.This four antennas form two antennas pair for being oriented to be separated by 180 degree, and provide Ratio measurement (ratio-metric) measurement to the Angle Position in skirt section 42.

Metal tape 172 is so shaped that the detectable skirt section 42 rotation position different relative to the one or more of module 82 It sets.Metal tape 172 has the shape for the signal that variation is generated when skirt section 42 is rotated relative to antenna 178.Illustratively, scheme 13A to Figure 13 C shows band model, and wherein Figure 13 B shows 90 ° of rotations from the position of Figure 13 A, and Figure 13 C is shown Additional 90 ° of rotations.The mode generates the sine-wave response detected when skirt section 42 is rotated relative to module 82, such as Figure 12 D In shown schematically in, wherein position a-d is associated with position shown in Figure 12 A.

Figure 13 D provides schematic diagram, and it illustrates the inductance type sensings in the module 82 and skirt section 42 that are incorporated into pen 10 Device system 170.Metal tape 172 is illustrated as being attached to skirt section 42.Antenna 178 is operationally connect with electronic equipment 120, so that Antenna play detection during dose delivery skirt section 42 relative to module 82 and therefore relative to the position of the shell 12 of pen 10 Effect.

In the embodiment shown in Figure 12 to Figure 13, inductance type transducer system 170 includes four sensing elements 176, This four sensing elements include the antenna 178 being spaced to equal radiuses in module 82.The alternative number of sensing element can be used The position and.For example, another embodiment utilizes individual antenna.In the illustrated embodiment, antenna 178 is illustrated as being attached at module In 82.Alternatively, (one or more) antenna could attach to any part of such component: the component is rotatably fixed To dose button 56 component is not rotated during dose delivery relative to shell 12.

For purposes of illustration, metal tape 172 is illustrated as being attached to the single tubular band of the outside in skirt section 42.However, structure Think alternative configuration and the position of metal tape 172.For example, metal tape may include multiple discrete hardwares.Implement at one In example, metal tape includes multiple element, and number is equal to the number of the discrete dose setting position in skirt section 42.It is substituting In example, metal tape could attach to any part that the component in skirt section 42 is rotationally fixed to during dose delivery, such as, flange 38 or dial member 32.Metal tape may include hardware, which is attached on the inner or outer side of rotating member The component or it can be incorporated into that in such component, such as by the metallic particles being incorporated in component, or pass through by The component and metal tape are overmolded.

Antenna 178 is schematically shown in Figure 12 A, and is shown as the antenna in structure in Figure 13 D and Figure 13 E It is round.The alternative configuration of antenna is schematically shown in Figure 13 F and Figure 13 G." elongate antenna " 180 is shown in Figure 13 F, It is with rectangle middle section 182 and semi-circular end 184.Figure 13 F depicts position of the antenna 180 relative to metal tape 186.The position It is in static corresponding to pen-type injector, does not have the axially displaced of the module as in dosage delivered.In Figure 13 G In, antenna 180 is in be pressed in the position to cause dose delivery corresponding to module.Module and therefore antenna 180 phase For the displacement of metal tape 186 (in Figure 13 G downwards).It is clear that elongate antenna 180 can provide to metal tape 186 more evenly Sensing because in the presence of the more constant region domains in the middle section 182 be overlapped with metal tape.

In an aspect, the dose measurement system of modular form is disclosed.The use for the module being removedly attached Particularly suitable for being used together with such drug delivery device: in the drug delivery device, actuator and dose The two is included in the part of medication device hull outside.These exterior sections allow sensing part to be directly attached to actuator (such as, dose button), and allow sensed component be directly attached to dose (such as, dosage skirt section, flange or Dial member), as described in this article.In this respect, " dose button " is for more generally referring to drug delivery device Such component: it includes the part outside the device housing and including can be used for for users to use to deliver setting The exposed surface of dosage.Similarly, dosage " skirt section " more generally refers to such component of drug delivery device: it is located at dress Set the outside of shell and thus have can be used for catching for user and rotatable parts so as to setting dosage expose portion.As herein Disclosed in, dosage skirt section rotates during dose delivery relative to dose button.Moreover, dosage skirt section can be in dosage setting Period is rotationally fixed to dose button, so that dosage skirt section or dose button can be rotated to setting dosage.It is substituting Property embodiment in, delivery apparatus may not include dosage skirt section, and user can catch and revolving actuator (for example, dose button) To carry out dosage setting.In some embodiments, the case where dose measurement module is attached to actuator and/or dosage skirt section Under, dose measurement module can be rotated, to rotate the dose of delivery apparatus thus to set dosage to be delivered.

In addition the disclosure is characterized in: the sensing system of dose measurement system 80 can be used as integrated system rather than as attached Add module and is initially incorporated into drug delivery device.

Foregoing teachings are provided for sensing opposite rotation of the dose relative to actuator during dose delivery The discussion of the various structures and methods turned.In some embodiments of drug delivery device, actuator during dosage setting with Spiral way is mobile relative to main body.For illustrative purpose, the disclosure is come about such actuator for the helical movement Dose measurement system is described.However, those skilled in the art will be appreciated that, the principle and object of disclosed dose measurement system Reason operation can also be with the rotation during dose delivery but the actuator not translated is used in combination.It will be further understood that dose measurement System can operate together with other configurations of medical delivery device, and condition is: the device include dosage injection during relative to The actuator of dose rotation.

Detection system can also be used together with the module of the characteristic of the drug for identification to be applied by pen-type injector.Pen Formula syringe is used together with various drugs, and is even used together with various types of given drugs.For example, depending on In expected purpose, insulin can be used in different forms.Insulin-type includes fast-acting type, short-acting type, middle acting type and long-acting type.? In another aspect, the type reference of drug is related to which kind of drug (for example, insulin is relative to non-insulin drug) and/or is related to Drug concentration.It is important that not obscure the type of drug, seriously affected because consequence may have.

The type of drug is possibly based on to be associated with certain parameters.Using insulin as an example, based on which is such as related to The insulin of seed type, insulin type how the factor with the time correlation connection of feeding dosage or the like, about feeding agent There are known limitations for the appropriate amount of amount.In another aspect, it is necessary to know apply which type of drug so as to accurately Monitoring and assessment treatment method.In an aspect, the sensing system that can distinguish the type of drug to be administered is provided.

In order to determine drug type, such module is provided, drug included in drug delivery device is detected The unique identification of type.When the module is installed to drug delivery device (for example, pen-type injector), module detects drug Type simultaneously stores it in memory.Hereafter, module is it is contemplated that the type of the drug in pen and previous feeding agent Amount history and other information set or deliver to assess drug.

With reference to Figure 14, pen-type injector 10 includes sensing system 200, which includes sensed component 202 With sensing part 204.Sensing system 200 can be operated to identify sensed difference of the component 202 relative to pen-type injector 10 Angle orientation.Sensing system 200 can be can identify that any type of specific Angle Position are (such as, previously described whereby Type).

In fig. 14 it is shown that pen-type injector 10 comprising shell 12, dose dial component 32, flange 38, clutch 52, dose button 56 and module 82.Sensed component 202 includes can uniquely know and be otherwise attached to pen-type injector 10 One or more be sensed element 206.By example, sensed element 206 be illustrated as being attached to skirt section 42 and relative to The orientation having the same always of skirt section 42.Skirt section 42 can be rotated relative to shell 12, but when in from pen-type injector point There is unique, identifiable position relative to shell 12 when in " initial null position " before any drug.Similarly, quilt Sensing element 206 could attach to other rotating parts of pen, these rotating parts are in correlation time (such as, by module During 82 are installed to pen-type injector 10) at there is the position that can uniquely identify.In this respect, being sensed element 206 can be with Alternatively it is attached to such as flange 38 or dial member 32.

Skirt section 42 includes the slot 208(Figure 15 axially extended on the outside of tubular skirt section wall 210).It predefines opposite In the Angle Position of sensed element 206 slot 208 Angle Position with corresponding with the drug of selected type.With reference to Figure 15, Slot 208 is illustrated as in 9 o'clock position, and wherein skirt section 42 is in its initial zero dose position.The position of slot 208 is assigned To represent certain types of drug.Alternatively, slot 208 is located in different Angle Positions for initial zero dose position, such as, 3 o-clock positions in Figure 15.The position is then designated as representing the drug of Second Type.Therefore, the sensed member of detection Part 206 is useful for identifying by the drug type that pen-type injector 10 is included relative to the position of slot 208.

Module 82 includes lower wall 212, which includes inner surface 214(Figure 16).Lug 216 from inner surface 214 it is radial to Interior extension, and be configured to be received in slot 208.This state is diagrammatically illustrated in Figure 15.Lug 216 can be interior The simple protruding portion on surface, or it is provided as the arm that can radially outward bend.In order to which module 82 is installed to device On 10, it is directed at lug 216 with slot 208, and the then propulsion die on the direction of device.Lug 216 is configured to pass through Guarantee with blunt front end 218 to be properly aligned with slot 208.This is provided to that lug 216 is required to be received in slot 208, And it not inadequately straddles on the another location on skirt section.

Figure 14 shows the module during installation, and wherein lug 216 is received in slot 208.In Figure 17, module 82 is It is advanced to its installation site, wherein lug 216 has been moved out of slot 208.In this position, module 82 can be fixed dosage Button 56, such as by protruding portion 220, as described previously.Lug 216, which is located in outside slot 208, to be allowed after mounting Relative rotation is carried out between skirt section 42 and module 82.

The identification of drug type is caused by sensed element relative to the predetermined orientation of slot 208.For Figure 14 to Figure 17 Embodiment, it means that sensed element is selectively positioned in the type that drug is represented on skirt section 42.With this side Formula, when lug 216 is aligned with slot 208, sensing system can operate with identification (one or more) be sensed element and The relative angular relation of module simultaneously therefrom obtains drug type.The detection can occur at any time that lug and slot are aligned.By In this alignment of needs at the time for attaching the module to skirt section, therefore at this time, detection position is advantageous.This can by with Any suitable way trigger sensor system and cause, such as, by proximity sensor, sliding contact, spring bias switch, Or pass through manual actuation when starting and installing module.

Once having installed module and having identified the type of drug, pen-type injector is ready for for using.Work as expectation When, module 82 is removed from pen-type injector, and can be used on another pen-type injector.During operation, dosage is passed Sending will be such that skirt section 42 rotates relative to module 82, so that lug and slot can be misaligned at the end of dose delivery.This does not influence pen The operation of formula syringe, because lug is axially displaced relative to slot 208 and therefore can be in any Angle Position relative to skirt section 42 In.However, lug 216 includes tapered back end 222 for the ease of remove module 82.This allows lug 216 to be easy to alter (ride Over it) arrives above the outer surface 210 in skirt section 42, the Angle Position regardless of skirt section.Lug and slot aligning guide has been used to describe Identification to drug type.However, being also contemplated by other align structures or system.

Drug type detection is useful to multiple sensors system, these sensing systems can be operated to detect sensed member Predetermined angle position of the part relative to alignment characteristics.These sensing systems include sensor system previously herein disclosed System.In addition aspect, which is that the drug type determines, to be easy to combine with the sensing system of the amount for detecting dose delivery.This Two systems can operate independently or consistent with each otherly.

In in a particular aspect, the sensing system for detecting dose delivery is also used for identification drug type.For example, Figure 10 Biosensor systems are described to Figure 11 and related text comprising sensing element 160 and magnet 152 are delivered to determine The amount of dosage.Magnet 152 has unique configuration, so that sensing system is able to detect magnet 152 relative to sensing element Specific Angle Position.Therefore, which can be used in combination with alignment characteristics, as described by Figure 14 to Figure 17 , to identify the drug type for being included by pen-type injector.The inductance type transducer system of Figure 12 to Figure 13 is for determination Another example of drug type and dose delivery both useful sensing system.

Referring to figs. 18 to Figure 21, alternative drugs and/or pen type detection system 230 are provided.In this embodiment, it passes Sensor system 230 is provided as connecting with module 232.Module 232 with the module 82 in the embodiment about Figure 14 to Figure 17 Described identical bonding pattern is removably attached to pen-type injector 10.Sensing system 230 includes sensed component 234 and sensor 236.Sensing system 230 can be operated to identify sensed difference of the component 234 relative to pen-type injector 10 Angle orientation.As described earlier, the identification of drug and/or pen type is taken by (one or more) sensed the predetermined of element To causing.Sensing system, which can be operated, to be sensed the relative angular relation of element and module with identification (one or more) and therefrom obtains Obtain drug and/or pen type.

The angle position of sensed component 234 is detected based on unique corner contours (angular profile) of sensed component It sets.Term " unique corner contours " is sensed the configuration of component for identification, including the one or more of sensed component 234 Sensed element 238 makes it possible to uniquely identify sensed component for any predetermined angle position to be used by system Angle Position.Figure 19 illustrates the sensed component with such unique corner contours into Figure 21.Figure 19 is diagrammatically illustrated Relationship between one embodiment and sensor 236 of sensed component 234.Sensed component 234 includes with roughly circular mould The single sensed element 238 that formula is formed.

Sensor 236 is shown as including opposite pairs of induction coil antenna 246 and 248 in Figure 20, they are about cause Position to the radiuses such as the rotation axis 242 of dynamic device 244.Antenna represents A+/A- and B+/B- pairing.Sensed component 234 such as Figure 20 Shown in position, be configured around rotation axis 242 rotation.AC electric current flowing passes through pairs of antenna 246 and 248, To generate four magnetic field AC individually and independently.

When sensed element 234 passes through antenna clock synchronization, the table of metal of the magnetic field of each antenna in sensed element 234 Cause the electric current (eddy current) of circulation on face.The eddy current causes the magnetic field of its own, the magnetic field and the original generated by antenna Beginning magnetic field is opposite.As the metal of sensed element 234 is mobile closer to aerial coil, the electromagnetic field that is generated by the coil Major part is intercepted, and the smaller portions of the electromagnetic field of other antennas are intercepted.It means that working as more electromagnetic field magnetic Eddy current increases when logical line is intercepted, and eddy current reduces when the less magnetic flux line of other coils is intercepted.In antenna This variation of eddy current in each changes the effective inductance of each separate antenna.System can measure each antenna 246 With 248 inductance these variations at any time, and eliminated using the data from opposite coil 246 and 248 due to temperature Undesirable difference caused by degree or mechanical tolerance.The result is that the waveform of two consecutive variations of 90 degree of out-phase, in Figure 21 It is shown.

Then, the corresponding level of two output signals can be with sensed component 234 relative to the various of sensor 236 Rotation position is associated, this allows orthogonal rotary sensing.System provides the response respectively from A and B antenna pair 246 and 248 Data A and data B.Sensing system 230 is shown in " 0 position " in Figure 20.From the shape of sensed component 234 with And exported from signal it is readily apparent that each relatively rotation place of sensed component 234 has unique response characteristic, and Therefore sensed component has unique corner contours of the rotation axis 242 around actuator 244.

The output signal is handled and decoded, specific characteristic is generated with the given position for sensed element 234.In this way Processing may include signal processing, with to output carry out repeated sampling or by analog signal shown in Figure 21 be converted into also at The individual digital square-wave of 90 degree of out-phase.Look-up table can be used for the current location information of comparison and previous location information to decode Moving direction.For example, if the upper solution code value of output signal A and B are respectively 00, and current value is 01, then can say and be felt It surveys element and has moved in a clockwise direction half step.It is determined for the degree of given " step " by the sample rate of analog signal.When When detecting the small change of Angle Position, increasing sample rate causes to rotate resolution ratio increase.However, in order to detect drug or device Type is sensed component and is directed to any Angle Position associated with drug or type of device or any other information to be detected It is enough for generating distinct signal output.

Sensing system 230 is configured to the one or more angles position for detecting sensed component 234 relative to sensor 236 It sets.Controller 250 makes a response one or more of Angle Positions detected, and thus can operate to determine about drug The information of delivery apparatus 10.

In the illustrative embodiments, module 232 is attached to actuator 244 with bonding relationships, thus relative to actuator By module 232 and therefore 244 sensor 236 is placed in predetermined angle position.For example, can be by receiving the slot 208 in skirt section 42 Lug 216(Figure 18 of module 232) it is bonded in mode identical in a manner of the embodiment for Figure 14 to Figure 17 to provide this Relationship.

The predetermined angle position of module 232 included with the type of drug delivery device 10 and/or by drug delivery device 10 Drug type it is associated.For example, 0 ° of position shown in Figure 20 can indicate that pen-type injector is that there is specific drug to hold The pen of amount, and 90 ° of positions can indicate that drug is intermediate acting insulins useful.For example, 180 ° of positions can indicate that drug delivery device is The pen-type injector of intermediate acting insulins useful comprising certain volume.These relevances can be stored in is deposited by what module 232 carried In reservoir.Controller is configured to the angle position for determining sensed component 234 relative to the sensor 236 for being included by module 232 Set and obtain the related information about drug delivery device.

In another illustrative embodiments, sensing system 230, which can be operated, to be delivered with determination by drug delivery device Drug amount.According to this embodiment, drug delivery device includes dose, and the dose is in dose delivery Period rotates relative to the main body of drug delivery device.During dosage setting, actuator is set with dosage in the first mode of operation Determine component axially and is rotatably fixed.During dose delivery, actuator is in the second mode of operation relative to apparatus main body It is non-rotatable.The detection of sensing system 230 is sensed rotation of the component relative to module, and controller during dose delivery Obtain the amount of delivered drug.

In a further embodiment, the sensing system of drug delivery device can be operated to determine about drug delivery device The information of itself and both the amounts of drug delivered by drug delivery device.In this embodiment, module 232 is attached to medicine Object delivery apparatus, and sensing system 230 detects sensed Angle Position of the component 234 relative to module 232.The position and medicine The type of object delivery apparatus, the type for the drug for being included by drug delivery device or any other desired information are associated. Then, drug is delivered using drug delivery device.During delivering, it is opposite that sensing system 230 detects sensed component 234 In the rotation of sensor 236, the instruction of the amount as the drug delivered.

With reference to Figure 18, the further exemplary details of drug delivery system 252 are provided.In Figure 18, system 252 includes Drug delivery device 10, the drug delivery device include apparatus main body 11, dose dial component 32, flange 38, skirt section 42, clutch Device 52 and dose button 56.Module 232 can be attached to dose button 56 by the protruding portion 220 to extend internally from module 232.It is logical Cross initial attachment, module 232 is orientated by the lug 216 that is received in slot 208 relative to skirt section 42.In this orientation, Sensed component 234 is associated with the type of the type of drug and/or drug delivery device relative to the position of sensor 236, As described earlier.

To carry out dose delivery, module 232 and dose button 56 are advanced to figure relative to skirt section 42 in a distal direction 21 position.In this position, when delivering the drug of doses, skirt section 42, dose dial component 32 and flange 38 are opposite In dose button 56 together moving in rotation.

Sensed component 234 includes the single sensed element for being provided as metal tape 254 as shown.Such as about figure 19 to described in Figure 21, and metal tape 254 has the unique corner contours for surrounding rotation axis 242.By example, it is sensed element 238 are illustrated as being attached to dose dial component 32.Dose dial component 32 can be rotated relative to apparatus main body 11, but worked as and be in When in " initial null position " before distributing any drug from drug delivery device relative to device housing 11 have it is unique, Identifiable position.Similarly, being sensed element 238 could attach to other rotating parts of drug delivery device, these can Rotating member has and can uniquely know at correlation time (such as, during module 232 to be installed to drug delivery device 10) Other position.In this respect, it is sensed component 234 and is alternatively attached to such as flange 38 or skirt section 42.

Illustrative sensing system 230 is as the system being integrated into drug delivery device rather than be provided as can Remove module is also useful.With reference to Figure 22, the drug delivery dress substantially the same with the device 10 in Fig. 1 to Fig. 4 is shown Set 310.Drug delivery device 310 includes apparatus main body 11 and dose 30, which includes that dosage is dialled Disk component 32, flange 38 and skirt section 42.These components are configured to work as previously described.Actuator 50 includes Clutch 52 and the dose button 56 for being attached to it.During dosage setting, dose button 56 and dose 30 rotate Ground is fixed.To carry out dose delivery, rotation fixation is detached from, and dose 30 is relative to dose button 56 and institute The amount of the dosage of delivering proportionally rotates.

The device 10 of drug delivery device 310 and Fig. 1 to Fig. 4 the difference is that include dose measurement system 312, The dose measurement system includes sensed component 314 and sensor 316.Sensor 316 is integrated into dose button 56.Dosage Button 56 includes substrate wall 318, peripheral wall 320 and roof 322, and they are formed together compartment 324.Sensor 316 includes The one or more sensors element 326 being supported in compartment 324.Similarly, single type dose button shown in Figure 26 56 may include integrated type sensor 316 and compartment 324.

Electronic equipment assembly 328 is also received in compartment 324, and is operationally connect with sensor element 326.Electricity Sub- apparatus assembly 328 further includes controller 330.Controller 328 couples with sensor element 320, simultaneously with receiving sensor output Thereby determine that the information about drug delivery device and/or its content.

Sensed component 314 is attached to dose 30.For the embodiment of Figure 18 to Figure 21, it is sensed component 314 include metal tape or other sensed elements with unique corner contours.Sensed component 314 is illustrated as being attached to dosage group Disk component 32, but it also could attach to the other component of dose 30.Sensor 316 is positioned and configured to detect The relative angular position of sensed component 314.

The embodiment and Figure 18 to Figure 21 the difference is that, the component of dose measurement system 312 is integrated into drug In delivery apparatus 310.In in other respects, sensing operation carries out as previously described, wherein dose measurement system into Row operation is to detect the type of drug delivery device, the type of drug and/or the dosage that is delivered by drug delivery device Amount etc..In another alternative, sensed component 314 is integrated into drug delivery device 310 again, but sensor 316 by Removable modules include as described earlier.

With reference to Figure 23 A to Figure 23 C, the alternate embodiment using optical sensing is shown.As described previously, module 82 It is attached to drug delivery device 10, which includes dose button 56 and skirt section 42.Sensed element includes applying To one or more detectable labels 350 of the upper surface 352 in skirt section 42.These labels may include for example being attached to skirt section 42 It can be seen that or invisible ink point.Sensing system includes the photomoduel 354 being mounted in compartment 96.354 quilt of photomoduel It positions and including suitable optical device, can be examined with tracking (one or more) relative to the rotation of module 82 through skirt section 42 Mark note.

In the similar embodiment shown in Figure 24 A to Figure 24 B for also using optical sensing, it is also provided that and is attached to medicine The module 82 of object delivery apparatus 10.Sensed component includes being applied to the one or more of the upper surface 368 of flange 38 to examine Mark note 360.Photomoduel 364 is positioned and including suitable optical device, to run through rotation of the flange 38 relative to module 82 Transfer tracking (one or more) detectable label 360.For example, photomoduel 364 can include: lens 366, be oriented with The window (not shown) of dose button 56 is aligned；And optionally recess 370, it is formed in the lug 94 of side wall 90.It can To provide detectable label 360 in various patterns, in order to monitor the rotation of flange 38.It will be appreciated that Figure 23 and Figure 24 Any one of embodiment can alternatively or additionally be used to based on the periphery for surrounding skirt section or flange include unique Detectable label detects the absolute relative position in skirt section or flange.

Alternatively, sensing system is illustrated as Capacitative sensor system 380 in Figure 25 A to Figure 25 C.Sensor system For system 380 using sensed element 382, which includes the metal tape 384 for being attached to skirt section 42.Sensing system 380 It further include sensor 386, which includes the one or more sensings for being mounted to the side wall 90 opposite with metal tape 384 Part, for example, antenna or armature 388.Metal tape for example covers the half on the periphery in skirt section 42, and when it is rotated about Z axis Capacitive coupling is generated between each pair of armature.It is separated by 180 ° of two armatures to forming two orthogonal sensors, and provides pair The ratio metric measurements of the Angle Position in skirt section.

Metal tape 384 is so shaped that detectable rotation position of the skirt section 42 relative to module 82.Metal tape 384 has The shape of the signal of variation is generated when skirt section 42 is rotated relative to antenna 384.When skirt section 42 rotates, the shape of metal tape 384 The position of shape and armature generates sine-wave response.Shielding part 390 on 90 outside of module wall is connected to device ground connection 392, and Isolation to sensor is provided during operation.

For purposes of illustration, metal tape 384 is illustrated as surrounding the internal stretch in skirt section 42 to the single tubular band of midway. However, also contemplating alternative configuration and the position of metal tape 384.For example, metal tape may include multiple discrete hardwares. In the alternative, metal tape could attach to any part that the component in skirt section 42 is rotationally fixed to during dose delivery, all Such as flange 38 or dial member 32.Metal tape may include hardware, and the hardware is on the inner or outer side of rotating member Being attached to the component or it can be incorporated into that in such component, such as by the metallic particles being incorporated in component, or By the way that the component and metal tape is overmolded.In Figure 26 in shown embodiment, the dosage of illustrated device 10 is pressed Button 56 is single type, both the skirt section 42 of a combination thereof Fig. 1 to Fig. 4 and dose button 56.In this embodiment, flange 38 is attached It is connected to dose dial component 32, and is cooperated with clutch 52 to select dose dial component 32 and single type dose button 56 Couple to property.The radially-outer surface of single type dose button 56 provides the surface outside main body 11 to be used for revolving dial component 32。

Pass through example and describes dosage in the case where the particular design (such as pen-type injector) of drug delivery device Detection system.However, illustrative dose measurement system can also be used together with alternative drugs delivery apparatus, and with can be with Other sensing configurations that mode described herein operates are used together.Any in device described herein can wrap Any one or more of drug described herein is included, such as, in the cylindrantherae of device.

Claims (59)

1. a kind of drug delivery device, the drug delivery device include:

Apparatus main body；

Dose, the dose are attached to described device main body and can be opposite during dose delivery It is rotated in described device main body；

Sensed element, the sensed element are rotatably fixed with the dose；

Actuator, the actuator are attached to described device main body and can be during dose deliveries relative to described device master Body is mobile；

Rotation sensor, the rotation sensor are attached to the actuator and to the sensed element in the dose delivery phase Between made a response relative to the relative rotation of the actuator；And

Controller, the controller make a response to detect the dosage setting during dose delivery the rotation sensor Amount of the component relative to the rotation of the actuator.

2. drug delivery device according to claim 1 is set wherein the sensed element is directly attached to the dosage Determine component.

3. drug delivery device according to claim 1, wherein the sensed element includes the dose Surface characteristics.

4. drug delivery device according to claim 1, wherein the dose is revolved during dosage setting Turn ground and be fixed to the actuator, the dose and the actuator are during dosage setting together relative to described Apparatus main body rotation and axial movement, the dose can revolve during dose delivery relative to the actuator Turn, during dose delivery, the actuator is moved axially and the dose is rotated relative to the actuator.

5. drug delivery device according to claim 1, the drug delivery device is described including being removably attached to The module of actuator, the rotation sensor are attached to the module.

6. drug delivery device according to claim 5, wherein the module includes the portion with the dose The tubular lower wall of split-phase pair, the sensed element are rotationally fixed to the part of the dose, the rotation Sensor is rotationally fixed to the tubular lower wall of the module.

7. drug delivery device according to claim 5, wherein the rotation sensor is magnetic sensor, optical sensing Device, inductance type transducer or capacitance type sensor.

8. drug delivery device according to claim 7, wherein the rotation sensor is adapted for the variation in magnetic field And output is generated, the controller makes a response the output from the rotation sensor, to detect during dose delivery Rotation amount of the dose relative to the actuator.

9. drug delivery device according to claim 5, wherein the actuator can be relative to the dosage setting structure Part axially moves, and with the first position relative to the dose and has relative to the dosage setting The second position of component, the actuator described in the first position are rotationally fixed to the dose, in institute Actuator described in the second position is stated to rotate freely relative to the dose.

10. drug delivery device according to claim 5, and the drug delivery device further includes switch, it is described to open Pass makes a response the pressure axially applied to activate the rotation sensor.

11. drug delivery device according to claim 5, wherein the dose includes skirt section, flange, driver plate At least one of component and surface characteristics.

12. a kind of method of the amount for the dosage that determination is delivered, which comprises

Main body relative to drug delivery device rotates simultaneously and to proximal translation dose setting device and actuator, described Setting dosage on drug delivery device, the dose setting device includes sensed element, and the actuator includes rotation Sensor；

After dose setting, the actuator is distally moved relative to the main body and thus cause the dosage setting structure Part rotates during being distally moved relative to the actuator；

During the movement, the relative rotation of the sensed element is detected using the rotation sensor；And

The amount of the delivered dosage is determined based on the relative rotation detected.

13. according to the method for claim 12, wherein the dose setting device is rotatably fixed during dosage setting To the actuator, and wherein, the dose setting device is rotated freely during dose delivery relative to the actuator.

14. according to the method for claim 13, wherein after setting dosage and before dosage delivered, the cause Dynamic device is axially moved towards the dose to set from being rotationally fixed to the actuator and discharge the dosage Determine component.

15. a kind of dose delivery measurement module for being used together with drug delivery device, the drug delivery device are included in Dose during dose delivery relative to actuator rotation, the dose delivery measurement module include:

Module housing, the module housing are adapted for attachment to the actuator of drug delivery device；

Rotation sensor, the rotation sensor are attached to the module housing and are oriented sensing dose phase Rotation for the actuator；And

Controller, the controller are attached to the shell and make a response the rotation sensor to detect and pass in dosage The amount of rotation of the dose relative to the actuator during sending,

When the shell is attached to the actuator, the shell limits the compartment for being located at the nearside of the actuator, described Controller is received in the compartment.

16. module according to claim 15, wherein the shell includes the table for frictionally engaging the actuator The physical form in face.

17. a kind of for measuring the kit utility of the amount of the dosage by drug delivery device delivering, the measuring device is included in Dose during dose delivery relative to actuator rotation, the kit utility include:

Module according to claim 15；And

Sensed element.

18. a kind of drug delivery system, the drug delivery system include:

Drug delivery device, the drug delivery device include the apparatus main body with the first keyed feature, first bonding Feature is configured to receive the complementary binding properties of detection module；

Detection module, the detection module are removably attached to the drug delivery device, and the detection module includes second Keyed feature, second keyed feature are configured to cooperate with first keyed feature to fill relative to the drug delivery It sets detection module orientation in predetermined angle position；

Sensed element, the sensed element is associated with the type of drug for being included by the drug delivery device The drug delivery device is attached in predetermined angle position；

It is attached to the sensor of the detection module, the sensor can be operated to detect the sensed element relative to institute State the Angle Position of detection module；And

Controller, the relative angular position that detects of the controller to the sensed element relative to the detection module are made The type for the drug for being included by the drug delivery device with determination is responded out.

19. drug delivery system according to claim 18, wherein the module includes memory, the memory has It is stored in the different Angle Positions therein for making sensed element related information relevant to different types of drug, and Wherein the controller can operate the type to determine drug based on the related information.

20. drug delivery system according to claim 18, wherein the module includes electronic building brick, the electronic building brick It can operate so that data associated with the type of drug are transferred to external device (ED).

21. drug delivery system according to claim 18, wherein the drug delivery device is pre-filled disposable Device.

22. drug delivery system according to claim 18, wherein the sensor includes magnetic sensor, electrical sensing Device or optical sensor.

23. drug delivery system according to claim 18, wherein the sensed element is opposite during dose delivery It is non-rotatable in described device main body.

24. drug delivery system according to claim 18, wherein the drug delivery device and detection module tool Have and depends on first keyed feature relative to the initial attachment position of the position of second keyed feature and final attachment Position, first and second keyed feature in the initial attachment position is in bond styles, in the bonding shape First keyed feature described in state by second keyed feature receive with relative to the drug delivery device by the detection Module is orientated in predetermined angle position, and first and second keyed feature in the final attachment location is in and is not bonded In state, the first keyed feature described in the non-bond styles is not received by second keyed feature and the detection Module is moved freely relative to the drug delivery device from the predetermined angle position.

25. drug delivery system according to claim 24, wherein one of described keyed feature is protruding portion, and The other of described keyed feature is recess portion, and the protruding portion is received in the recess portion in the initial attachment position It is interior.

26. drug delivery system according to claim 25, wherein protruding portion phase in the final attachment location The recess portion is axially shifted.

27. drug delivery system according to claim 26, wherein when the drug delivery device and the detection module When in the initial attachment position, the sensor can be operated to detect the sensed element relative to the detection mould The Angle Position of block.

28. drug delivery system according to claim 18, wherein the drug delivery device includes dose, The dose can rotate during dose delivery relative to described device main body, and the sensed element is attached to The dose.

29. drug delivery system according to claim 28, wherein the dose includes extending to the dress The skirt section of body exterior is set, the sensed element is attached to the part in described device body exterior in the skirt section.

30. drug delivery system according to claim 29, wherein the detection module includes wall, the wall includes and institute The opposite part of the exterior portion in skirt section is stated, the sensor is positioned on the opposite segments of the wall.

31. drug delivery system according to claim 28, wherein the sensed element be rotationally fixed to it is described Dose, the drug delivery device further include during dose delivery relative to the non-rotary cause of described device main body Dynamic device, the sensor are attached to the actuator during dose delivery.

32. drug delivery system according to claim 31, wherein the sensor is also to the sensed element in agent Rotation during amount delivering relative to the actuator makes a response, and the controller makes a response to detect the sensor Amount of the dose during dose delivery relative to the rotation of the actuator.

33. drug delivery system according to claim 31, the drug delivery system additionally includes rotation sensor, The rotation sensor makes a response rotation of the sensed element during dose delivery relative to the actuator, institute Controller is stated to make a response the rotation sensor to detect the dose during dose delivery relative to institute State the amount of the rotation of actuator.

34. a kind of delivery method, the delivery method include:

Drug delivery device is provided, the drug delivery device includes the apparatus main body with the first keyed feature, and described first Keyed feature is configured to receive the complementary binding properties of detection module, and the drug delivery device has sensed element, institute State the drug that sensed element is oriented in relative to the drug delivery device and is included by the drug delivery device In the associated predetermined angle position of type；

It will test module and be removably attached to the drug delivery device, the detection module has the second keyed feature, institute The second keyed feature is stated to cooperate with first keyed feature to take the detection module relative to the drug delivery device To in predetermined angle position, the drug delivery device includes sensor, and the sensor can be operated to detect and described be felt Survey Angle Position of the element relative to the detection module；

The sensed element is detected using the detection module for being attached to the drug delivery device relative to the inspection Survey the Angle Position of module；And

The medicine for being included by the drug delivery device is determined based on the relative angular position of the sensed element detected The type of object.

35. delivery method according to claim 34, wherein the sensed element is opposite during dose delivery It is non-rotatable in described device main body.

36. delivery method according to claim 34, wherein the drug delivery device and detection module tool Have and depends on first keyed feature relative to the initial attachment position of the position of second keyed feature and final attachment Position, first and second keyed feature in the initial attachment position is in bond styles, in the bonding shape In state, first keyed feature by second keyed feature receive with relative to the drug delivery device by the detection Module is orientated in predetermined angle position, and first and second keyed feature in the final attachment location is in and is not bonded In state, the first keyed feature described in the non-bond styles is not received by second keyed feature and the detection Module is moved freely relative to the drug delivery device from the predetermined angle position, the method also includes:

The detection module is attached to the drug delivery device in the initial attachment position；

In the initial attachment position, the quilt is detected using the detection module for being attached to the drug delivery device Angle Position of the sensing element relative to the detection module；And

Hereafter, the detection module is made axially to be displaced to second attachment location.

37. delivery method according to claim 36, wherein one of described keyed feature is protruding portion, and The other of described keyed feature is recess portion, and the protruding portion is received in the recess portion in the initial attachment position It is interior.

38. the delivery method according to claim 37, wherein the protruding portion in the final attachment location from The recess portion axially shifts.

39. delivery method according to claim 34, wherein the drug delivery device includes dose, The dose can rotate during dose delivery relative to described device main body, and the sensed element is attached to The dose.

40. delivery method according to claim 39, wherein the sensed element be rotationally fixed to it is described Dose, the drug delivery device further include during dose delivery relative to the non-rotary cause of described device main body Dynamic device, the method also includes the sensor is attached to the actuator.

41. delivery method according to claim 40, wherein the sensor is also to the sensed element in agent Rotation during amount delivering relative to the actuator makes a response, the method also includes:

Rotation of the dose during dose delivery relative to the actuator is detected using the sensor Amount.

42. delivery method according to claim 40, the delivery method additionally includes rotation sensor, The rotation sensor makes a response rotation of the sensed element during dose delivery relative to the actuator, institute State method further include:

The dose is carried out using the rotation sensor during dose delivery relative to the actuator The detection of the amount of rotation.

43. a kind of drug delivery system, the drug delivery system include:

Drug delivery device, the drug delivery device include the apparatus main body with the first keyed feature, first bonding Feature is configured to receive the complementary binding properties of detection module, and the drug delivery device includes dose, described Dose is attached to described device main body and can be relative to described device main body around rotation during dose delivery Axis rotation；

Detection module, the detection module are removably attached to the drug delivery device, and the detection module includes second Keyed feature, second keyed feature and first keyed feature cooperate with will be described relative to the drug delivery device Detection module is orientated in predetermined angle position；

It is attached to the sensed component of the dose, the sensed component includes around the dose Unique corner contours of rotation axis；

It is attached to the sensor of the detection module, the sensor can be operated to detect the sensed element relative to institute State one or more Angle Positions of sensor；And

Controller, the controller detect the sensed element relative to the one or more of of the sensor Angle Position makes a response to determine the information about the drug delivery device.

44. drug delivery system according to claim 43, wherein the controller be configured to based on one or Multiple Angle Positions detected determine the type and/or drug delivery device of the drug for being included by the drug delivery system Type.

45. drug delivery system according to claim 44, wherein the sensed component with by the drug delivery Described dose is attached in the type for the drug that device is included and/or the associated predetermined angle position of the type of drug delivery device Measure setting element.

46. drug delivery system according to claim 43, wherein the controller be configured to based on one or Multiple Angle Positions detected determine the amount of the drug delivered by the drug delivery device.

47. drug delivery system according to claim 46, wherein the drug delivery device further include be attached to it is described The actuator of apparatus main body, the actuator are axial with the dose in the first mode of operation during dosage setting It ground and rotatably fixes, the actuator can not be revolved relative to described device main body in the second mode of operation during dose delivery Turn, the sensed element and the dose are relatively opposite with the amount of the dosage delivered during dose delivery It is rotated in the actuator.

48. drug delivery system according to claim 47, wherein the actuator includes dose button, and the biography Sensor is attached to the dose button.

49. drug delivery system according to claim 48, wherein the dose includes dose dial component, And the sensed component is attached to the dose dial component.

50. drug delivery system according to claim 49, wherein the controller is further configured to based on one Or multiple Angle Positions detected fill come the type and/or drug delivery for determining the drug for being included by the drug delivery system The type set.

51. a kind of drug delivery device, the drug delivery device include:

Apparatus main body；

Dose, the dose are attached to described device main body and can be opposite during dose delivery It is rotated in described device main body around rotation axis；

The sensed component for being attached to the dose and rotatably being fixed with the dose, it is described to be felt Survey unique corner contours that component includes the rotation axis around the dose；

Be attached to the actuator of described device main body, the actuator during dosage setting in the first mode of operation with described dose Amount setting element is axially and rotationally fixed, and the actuator is during dose delivery in the second mode of operation relative to described Apparatus main body is non-rotatable, the sensed element and the dose during dose delivery with the dosage that is delivered Amount relatively relative to the actuator rotate；

It is attached to the sensor of the actuator, the sensor is configured to detect the sensed element relative to the biography One or more Angle Positions of sensor；And

Controller, the angle position that the controller detects the sensed element relative to the one or more of the sensor It sets and makes a response to determine the information about the drug delivery device.

52. drug delivery device according to claim 51, wherein the controller be configured to based on one or Multiple Angle Positions detected determine the type and/or drug delivery device of the drug for being included by the drug delivery device Type.

53. drug delivery device according to claim 51, wherein the controller be configured to based on one or Multiple Angle Positions detected determine the amount of the drug delivered by the medication device.

54. drug delivery device according to claim 53, wherein the controller is further configured to based on one Or multiple Angle Positions detected fill come the type and/or drug delivery for determining the drug for being included by the drug delivery device The type set.

55. drug delivery device according to claim 54, wherein the sensed component with by the drug delivery Described dose is attached in the type for the drug that device is included and/or the associated predetermined angle position of the type of drug delivery device Measure setting element.

56. drug delivery device according to claim 55, wherein the sensed component includes one or more metals Element.

57. drug delivery device according to claim 56, wherein the sensed component includes the continuous of change width Metal tape, the metal tape extend around the rotation axis of the dose.

58. drug delivery device according to claim 51, wherein the actuator includes dose button, and the biography Sensor is attached to the dose button, and wherein the dose includes dose dial component, and described is felt It surveys component and is attached to the dose dial component.

59. drug delivery device according to any one of the preceding claims, the drug delivery device includes drug.